NCT01775787

Brief Summary

This study will examine whether nicotine levels increase with electronic cigarettes. It will also examine whether electronic cigarettes alter lung function tests. The study will obtain preliminary data on the medical effects of electronic cigarettes, with two different nicotine flavors, tobacco and tobacco with menthol, which are available for over the counter purchase. The electronic cigarettes and juice used in this study is available for purchase through the internet. An investigational new drug application (IND) is not needed for this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

November 30, 2017

Completed
Last Updated

November 30, 2017

Status Verified

October 1, 2017

Enrollment Period

2.7 years

First QC Date

October 12, 2012

Results QC Date

November 18, 2016

Last Update Submit

October 24, 2017

Conditions

Health Behavior

Keywords

smoking

Outcome Measures

Primary Outcomes (1)

  • Effects E-cig Use on Venous Nicotine Concentrations Before and 5 Minutes After Use

    To determine the effects of acute E-cig use on venous nicotine concentrations 5 minutes before and 5 minutes after 7-10 days of e-cigarette use.

    7-10 days

Study Arms (2)

Tobacco Flavor/ Tobacco & Menthol Flavor

OTHER

Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days. Nicotine with Tobacco Flavor and Tobacco \& Menthol Flavor (18mg/mL nicotine)

Drug: Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor

Tobacco & Menthol Flavor/Tobacco Flavor

OTHER

Subjects randomized to Tobacco and Menthol Flavor for 7-10 days,then crossed over to Tobacco Flavor for 7-10 days. Nicotine with Tobacco Flavor and Tobacco \& Menthol Flavor (18mg/mL nicotine)

Drug: Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor

Interventions

Nicotine with Tobacco Flavor and Tobacco & Menthol FlavorDRUG

Subjects randomized to either Tobacco Flavor group for 7-10 days than crossed over to Tobacco \& Menthol Flavor for 7-10 days or Tobacco \& Menthol Flavor group for 7-10 days than crossed over to Tobacco Flavor for 7-10 days

Also known as: Tobacco Flavor, Tobacco & Menthol Flavor, Electronic Cigarette, Nicotine
Tobacco & Menthol Flavor/Tobacco FlavorTobacco Flavor/ Tobacco & Menthol Flavor

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Smoking 10 cigarettes daily
  • Agree to abstain from smoking and use electronic cigarettes for 2 weeks

You may not qualify if:

  • Unstable medical or psychiatric disorders as determined by the principal investigator
  • Pregnancy
  • Known hypersensitivity to nicotine or propylene glycol or menthol
  • Recent M. I. or stroke
  • Uncontrolled hypertension (BP.\>160/100)
  • Insulin dependent diabetes
  • Known COPD or asthma
  • Alcohol or other drug abuse or dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030-3940, United States

Location

Related Publications (1)

  • Oncken CA, Litt MD, McLaughlin LD, Burki NA. Nicotine concentrations with electronic cigarette use: effects of sex and flavor. Nicotine Tob Res. 2015 Apr;17(4):473-8. doi: 10.1093/ntr/ntu232.

    PMID: 25762758RESULT

Related Links

MeSH Terms

Conditions

Health BehaviorSmoking

Interventions

NicotineTobacco ProductsMentholElectronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingSmoking DevicesManufactured MaterialsTechnology, Industry, and AgricultureCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexane MonoterpenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsMonoterpenesTerpenesLipids

Results Point of Contact

Title
Dr. Cheryl Oncken
Organization
UConn Health
oncken@uchc.edu
860-679-3425

Study Officials

  • Cheryl Oncken, M.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Medicine

Study Record Dates

First Submitted

October 12, 2012

First Posted

January 25, 2013

Study Start

October 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 30, 2017

Results First Posted

November 30, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)